Recall Z-1961-2016 · PLF Bone Wedge
Arthrex, Inc.
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
| Date | Apr 22, 2016 |
| Status | Terminated |
| Reason | Potential for polystyrene particulate presence. |
| Root cause | Material/Component Contamination |
| Action | On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorizati |
| Quantity | 138 total products |
| Distribution | Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151256 | Arthrex BioSync® Bone Wedge Arthex, Inc., Aug 12, 2015 |